Ankle Implant for Arthritis

Recruiting at 10 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: Surgical procedure

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies a special ankle implant for patients needing ankle surgery. It aims to see how well the implant works in reducing pain and improving function. The implants have been developed to improve stability and longevity, with advancements in design and materials.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Zimmer Trabecular Metal Total Ankle System treatment for arthritis?

Studies show that the Zimmer Trabecular Metal Total Ankle System can provide reliable pain relief and good functional results for patients with ankle arthritis, with most implants remaining stable over several years. This treatment helps preserve ankle motion and reduces stress on other foot joints, which is beneficial compared to other surgical options. ^{1 2 3 4 5}

How is the Zimmer Trabecular Metal Total Ankle System treatment different from other treatments for ankle arthritis?

The Zimmer Trabecular Metal Total Ankle System is unique because it uses a lateral approach with a fibular osteotomy (cutting the fibula bone) to access the ankle joint, which is different from traditional methods. This approach may offer better access and potentially improved outcomes for patients with end-stage ankle arthritis. ^{1 2 3 4 6}

Research Team

Hillary Overholser, MS

Principal Investigator

Zimmer Biomet

Eligibility Criteria

This trial is for adults over 18 with arthritis (degenerative, rheumatoid, or post-traumatic) who need ankle replacement surgery. They must be able to consent and follow the study's procedures. Excluded are prisoners, those mentally unable to participate, non-compliant individuals, pregnant women, patients with infections or poor bone quality, and those with severe limb issues.

Inclusion Criteria

I am older than 18 years.

The patient is willing and able to provide written informed consent

My bones have stopped growing.

Exclusion Criteria

The patient has a known sensitivity or allergic reaction to one or more of the implanted materials

The patient is unwilling or unable to give consent or to comply with the follow-up program

I am not a prisoner, mentally competent, understand the study, and do not abuse substances.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Evaluation

Participants undergo preoperative clinical evaluations prior to their primary or revision total ankle arthroplasty

1-2 weeks

Treatment

Participants receive the Zimmer Trabecular Metal Total Ankle System during primary or revision total ankle arthroplasty

Surgical procedure

Post-operative Evaluation

Post-operative clinical and radiographic evaluations conducted at 6 weeks, 6 months, 1 year, 2, 3, 5, 7, and 10 years

10 years

Multiple visits over 10 years

Follow-up Surveys

Follow-up surveys conducted at 4, 6, 8, and 9 years to assess long-term outcomes

10 years

Treatment Details

Interventions

• Zimmer Trabecular Metal Total Ankle System

Trial Overview The Zimmer Trabecular Metal Total Ankle System is being tested in people needing ankle replacements due to arthritis. The study aims to track how well the implant works by looking at pain relief, improved function, life quality measures and checking x-rays for durability.

Participant Groups

Group I: Zimmer TM Total Ankle System Experimental Treatment 1 Intervention

Primary or revision total ankle arthroplasty subjects that receive the Zimmer Trabecular Metal Total Ankle System

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

References

1. United States pubmed.ncbi.nlm.nih.gov

Fixed-Bearing Trabecular Metal Total Ankle Arthroplasty Using the Transfibular Approach for End-Stage Ankle Osteoarthritis: An International Non-Designer Multicenter Prospective Cohort Study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Early clinical and radiological evaluation in patients with total ankle replacement performed by lateral approach and peroneal osteotomy. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of the Lateral Trabecular Metal Total Ankle Replacement at a 5-Year Minimum Follow-up. [2023]

4. France pubmed.ncbi.nlm.nih.gov

Total ankle replacement through a lateral approach: surgical tips. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Total ankle replacement in patients with rheumatoid arthritis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Early Clinical Outcomes and Complications of Transfibular Total Ankle Arthroplasty: The Australian Experience. [2023]